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IRCT20100314003566N9 IRCT 2018-03-04 Vice chancellor for Research,Tabriz University Of Medical Sciences Comparative efficacy of intralesional Cryotherapy vs intralesional Corticosteroi 5 Fluorouracil in the treatment of hypertrophic scars and keloids Comparative efficacy of intralesional Cryotherapy vs intralesional Corticosteroid 5 Fluorouracil in the treatment of hypertrophic scars and keloids 2018-01-30 anticipated 63 Complete https://irct.ir/trial/29236 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This research is double-blinded experimental, interventional (clinical trial) study, in which researcher and patient are not aware of the treatment method, and patients would be distinguished with manual coding. The patients are then randomly assigned to three distinct groups randomly by a random number table, Blinding description: This research is double-blinded experimental, interventional (clinical trial) study, in which researcher and patient are not aware of the treatment method, and patients would be distinguished with manual coding.The checklist will be prepared by the executor and will be completed individually for each patient, and then the patients will be randomly assigned to three distinct groups randomly by random number table, and each step will be evaluated by assistant. Each method is performed by needle insertion after anesthesia which patient will be not aware of the material. The research is performed by executor and treatment response is analyzed by assistant. 2-3 Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Intervention 1: Intervention group: The first group will be treated with Intra lesional cryotherapy(sarmadarman co./iran) alone.In this method, a liquid nitrogen at a temperature of -196 c through a probe leads to freezing of the lesion.Treatment every 4 weeks, depending on the scar tissue, will be repeated up to 6 sessions. Intervention 2: Intervention group 2: Triamcinolone 40 mg / ml will be injected by 27 gauge needle into the lesion in the amount of 0.2 ml / cm² (steroid used in this study is triamhexal.)Treatment every 4 weeks, depending on the scar tissue, will be repeated up to 6 sessions. Intervention 3: Intervention group3: 5Fluorouracil(EBEWE.CO) 250 mg / 5mg (0.2 ml / cm²) will be injected into the lesion by 27gauge needle.Treatment every 4 weeks, depending on the scar tissue, will be repeated up to 6 sessions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the completion of the project, the decision will be made.
public Hamide Azimi
Dermatology ward, Sina Hospital, Azadi Ave.
Tabriz Iran (Islamic Republic of) 51386631357 +98 41 3553 9161 azimi@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Hamide Azimi
Dermatology ward, Sina Hospital, Azadi Ave. خیابان آزادی، بیمارستان سینا، بخش پوست
Tabriz Iran (Islamic Republic of) 51386631357 +98 41 3553 9161 azimi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients withof hypertrophic scars and keloids Age 12 and older 12 years no limit Both Pregnant Breastfeeding women Age less than 12 years history of allergy to the drugs used in the research liver and kidney disease Immune system deficiency Reduction in blood cell levels L99 Other disorders of skin and subcutaneous tissue in diseases classified elsewhere Treatment - Other Treatment - Drugs Treatment - Drugs Intervention group: The first group will be treated with Intra lesional cryotherapy(sarmadarman co./iran) alone.In this method, a liquid nitrogen at a temperature of -196 c through a probe leads to freezing of the lesion.Treatment every 4 weeks, depending on the scar tissue, will be repeated up to 6 sessions. Intervention group 2: Triamcinolone 40 mg / ml will be injected by 27 gauge needle into the lesion in the amount of 0.2 ml / cm² (steroid used in this study is triamhexal.)Treatment every 4 weeks, depending on the scar tissue, will be repeated up to 6 sessions. Intervention group3: 5Fluorouracil(EBEWE.CO) 250 mg / 5mg (0.2 ml / cm²) will be injected into the lesion by 27gauge needle.Treatment every 4 weeks, depending on the scar tissue, will be repeated up to 6 sessions. Scar Volume. Timepoint: Every 4 weeks, depending on the scar tissue, up to 6 sessions. Method of measurement: Using the vernier scale tool. Complications of treatment. Timepoint: Monthly, up to 6 months. Method of measurement: Clinical observation. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2017-06-08 Ethics Committee Of Tabriz University Of Medical Sciences. Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)